Muhammad Akhtar
The Islamia University of Bahawalpur, Pakistan
Title: In vivo kinetics of modified release gastroprotective combination in healthy male volunteers
Biography
Biography: Muhammad Akhtar
Abstract
The study was aimed to evaluate pharmacokinetic parameters of sustained release combined formulation of ibuprofen and misoprostol tableted microspheres. The study was conducted in 18 healthy male volunteers. A single dose as tablet was administered through oral route. The plasma concentrations of drugs were assessed by development of reverse phase HPLC method and blood samples were taken over a period of 12 h post drug administration. Non-compartmental method of analysis was used for evaluation of pharmacokinetic parameters. Maximum plasma drug concentration (Cmax) and time (tmax) to reach Cmax were determined directly from the data. Area under plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-t) was calculated using linear trapezoidal rule. In addition, absorption parameters were also calculated. Kinetica® software version 4.4.1 was used for these calculations. Computer based MS-Excel was used to determine mean ± SD values. The current HPLC method was found suitable for simultaneous determination of ibuprofen and misoprostol. The Cmax values (mean ± SD) of 26.68±2.32 and 0.17±0.01 for ibuprofen and misoprostol were observed, respectively. The values (mean ± SD) of T¬max and AUC0-∞ were 1.89±0.47 and 179.81±22.87 for ibuprofen while 1.36±0.54 and 0.84±0.04 for misoprostol, respectively. The current study reported improved bioavailability and estimation of the quantifiable concentrations of both drugs in plasma for a prolonged period of time by successfully developing a fixed-dose combination of both IBN and MIS as tableted microspheres.